Total Recall Disclosure... Or Not So Much

Written by Mike Hoskins
| Published on January 14, 2014

If one of my medications or diabetes supplies is deemed potentially unsafe, I want to know about it. ASAP.

But even if I'm not a current consumer of a product deemed "problematic" by the powers-that-be, I still want to know about any potential new or existing safety issues. I might be a future customer myself or it might be a matter of getting word out to the rest of the community so my peers know about these issues and can take action.

In this day and age of living in the web fast-lane, the urgency of sharing recall information seems pretty obvious and paramount. These days, the power of social media and the online universe, we never have to be left in the dark when these issues come up, because so many are helping to get word out and share details as soon as they're available.

Yet a look back on recent recalls in the D-world raises an interesting question: who gets word of them first -- existing customers or the public at large? -- and is there a "best practices" standard for sharing this kind of news with the Diabetes Community?

There may not be, but we have to wonder if there should be, or whether opinions differ too much on how people want to learn about medical product recalls?

Just last week, Tandem voluntarily recalled a batch of t:slim insulin pump cartridges because of potential leaking. No one reported being injured or hurt as a result (see also: no "adverse events"), but there was that possibility. Tandem apparently discovered this issue during an internal product test, and made the choice to immediately and publicly issue the recall that impacted 22 different lot numbers (a total of 4,746 boxes of cartridges) shipped on or after Dec. 17, 2013.

Within an hour of the recall being issued, Tandem had sent out a news release online, posted the information on the News section of its website, and began sending word out via social media. Many of us in the DOC helped spread the word, too, so that as many people as possible could learn about this and find out if their own supplies might be included.

Update: On Jan. 20, Tandem Diabetes expanded the recall to include a total of 55 lot numbers (instead of the 22 that had originally been affected), and the included cartridges would have been shipped before Oct. 16, 2013.

Bravo, Tandem.

While this "full web disclosure" approach may seem like common sense today, not every diabetes company operates this way. Some do, of course -- like Abbott Diabetes Care, that issued a voluntary test strip recall in mid-November for FreeStyle and FreeStyle Lite strips, which could display false low blood sugars. The company disclosed the recall in much the same way with the same result, and it's also worth noting how visually helpful the Abbott website was, including pictures of the impacted meters that might use any of the 20 lots of strips, instead of just listing them in boring gray... text.

But also in November, we saw that Asante Solutions, makers of the Snap insulin pump, didn't follow this same disclosure logic.

They were part of a recall about the same time as Abbott in mid-November, this one involving the Asante Comfort and Conset infusion sets that were coming disconnected from the tubing and potentially leaking insulin. The infusion sets weren't specifically made by Asante, but rather produced by Unomedical (a division of Denmark-based ConvaTec) that makes most of these types of diabetes device supplies. The Asante Snap pump system and its users were certainly affected, yet the insulin pump maker took to sharing news of the recall... in a different way.

The company made a policy decision to first notify Asante Snap users before letting the public at large in on the details. What this means is that they spent days sending out letters and making phone calls to their customer base before ever posting a whisper of the news publicly, online.

Here's the explanation given by Ed Sinclair, VP of regulatory and quality affairs for Asante:

Asante is committed to placing people with diabetes first. The priority of our entire company last week (week of Nov. 21) was to get in touch with all pumpers currently using Snap. As soon as the recall was announced, we sent out the recall letter and shipped replacement product to all impacted Snap users. We next called all current pumpers to review the situation, confirm they received the letter and replacement product, and answer any questions they may have had. We reached many of these people on the first attempt, but we spent the remainder of the week following up to make sure we got in touch with everyone. Our outside sales team has been calling on healthcare professionals since last week to make sure they understand the situation and have visibility to how Asante is helping to take care of their patients. Finally, we wanted to get this information out there to you and the rest of the community. We want you to know that anyone who was directly impacted has already been contacted and has received replacement product.

OK, I get where Asante's coming from. Yes, high-touch customer service is important and desirable. But are they missing the forest for the trees here?

To me, it seems a little misguided not to put the word out publicly, online, so that customers and others can learn about the problem immediately.

In my dozen years of using an insulin pump, I've seen my share of recall notices. It was definitely tougher back in the days before blogs, Twitter and Facebook, when we didn't (couldn't!) hear about these problems until receiving a call or letter from my company. Or unless there was a big mainstream media news story that eventually hit. But heck, times have changed!

Now, everything's online. And that is just where society turns to get information first (for better or worse).

Usually now, companies post notices immediately, making it easy for us users to answer our key questions: 1. Am I affected? 2. What do I do about it? 3. Where can I turn to get more information if I need it?

So if I hear word of a recall and don't see anything posted online? I'm a little doubtful -- possibly even worried that the company's trying to hide something. It just seems odd, in today's tech-savvy world, not to share the information in as many places as possible right at the get-go, no?

But wow -- a whole week before this was shared publicly!! Especially when, according to the recall letter sent out, 15 complaints had been received and some patients reported high blood sugars even getting up to potential DKA levels as a result. Yikes!

Take this hypothetical, for example: I'm an Asante Snap user impacted by this recall, but it comes at a time when I'm traveling (for the Holidays, as this one did right before Thanksgiving). I am not at my home number you have on file, and also am not at home to receive the letter you've FedEx'd to me.

Since there's no word about this anywhere online, I keep using my faulty infusion sets as normal and, unfortunately, one malfunctions and causes a problem that negatively impacts my health.

If this had been shared like pretty much all other news in the world today, I might have at least known to call the company to ask about it. Or better yet, I could've saved myself and the company a call by just clicking on a news release or the Asante site to see the specific product information for myself and make a determination about what I need to do.

In the end, we're all just trying to make sure the people impacted by any recall are aware of what's happening. Those of us who are active in the DOC try our best to access this information immediately so we can help share it, in a timely and accurate manner. But when companies don't play ball by going public right away, it just creates confusion and possible customer backlash.

Opinions may vary, like everything else in diabetes... What do you think?

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community.
The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines.
For more information about Healthline's partnership with Diabetes Mine, please click here.

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